Micronutrients in Management of Symptomatic Oral Lichen Planus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-09-01

Brief Summary

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Treatment of oral lichen planus is challenging. Diverse therapeutic modalities have been suggested, but a permanent cure is not yet available. In some OLP patients, topical corticosteroid alone is not sufficiently enough, thus it may require a supplementation to augment its effect. Micronutrients are gaining more attention as therapeutic modalities in immunologic disorders. Researchers are recommended to conduct further clinical studies are to assess the role of these elements in management of OLP (Gholizadeh \& Sheykhbahaei, 2020). Among the less visited micronutrients are zinc and vitamin D. This trial will assess their role in management of OLP.

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Detailed Description

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The enrolled patients will be divided randomly into three groups. One group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily, the second group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic zinc (Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma) twice daily and the third group will receive topical Corticosteroid (Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm) four times daily with systemic vitamin D (Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals) once daily. The patients will be recalled weekly for eight weeks. For every four weeks of topical corticosteroid application, topical oral antifungal (Daktarin 2% oral gel - miconazole) will be prescribed, four times daily for one week, to all the patients in the trial, to avoid secondary infection with oral candidiasis. The patients will be asked to prohibit the use of any topical or systemic medication during the trial.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Topical Corticosteroid with Systemic Zinc.

Octozinc: Zinc sulphate heptahydrate 25 mg tablets - October Pharma

Group Type ACTIVE_COMPARATOR

Zinc sulphate heptahydrate

Intervention Type DIETARY_SUPPLEMENT

Dietary supplements

Topical Corticosteroid with Systemic Vitamin D

Cholecalciferol: vitamin D3 15 ml oral solution - Medical Union Pharmaceuticals

Group Type ACTIVE_COMPARATOR

Zinc sulphate heptahydrate

Intervention Type DIETARY_SUPPLEMENT

Dietary supplements

Topical Corticosteroid

Kenacort A Orabase: triamcinolone acetonide 0.1% adhesive paste - Dermapharm

Group Type OTHER

Zinc sulphate heptahydrate

Intervention Type DIETARY_SUPPLEMENT

Dietary supplements

Interventions

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Zinc sulphate heptahydrate

Dietary supplements

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol: vitamin D3 oral solution

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from erosive or atrophic OLP
* Patients free from any visible oral lesions other than OLP.
* Patients who agreed to take the supplied interventions.
* Patient who will agree to participate in the study.
* Patients who will accept to sign the informed consent.

Exclusion Criteria

* Patients suffering from any systemic disease.
* Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
* Treatment with any oral topical medications for at least four weeks prior to the study.
* Pregnant and lactating mothers.

Eligible Sex

ALL

Accepts Healthy Volunteers

No